ALIM cc
seekingalpha.com
SEVERE EDIT
We are on target to begin generating revenue in the first quarter of 2013.
We will begin with initial launch in Germany,
followed by subsequent launches in the United Kingdom during the second quarter
and France in the third quarter of 2013.
Our planning for ILUVIEN commercialization at EU is well underway. And I'm pleased to announce that we've identified and
hired our European senior management team and have been working closely with our contract sales organization to build out our initial country organizations.
As a result, we will have Alimera-dedicated personnel in the field in the fourth quarter preparing the markets for launch. Additionally, we expect to ship 3 commercial batches of ILUVIEN to our European quality testing facility in the United Kingdom this week.
Turning to the United States for a moment. We intend to resubmit our NDA for ILUVIEN during the first quarter of 2013. Based on the meeting with the U.S. Food and Drug Administration in June of 2012 to discuss the FDA's November 2011 Complete Response Letter regarding our New Drug Application for ILUVIEN for the treatment of DME, we intend to resubmit our NDA using data from our 2 previously completed pivotal Phase III clinical trials. We will focus on the population of patients with chronic DME, similar to the marketing approval for ILUVIEN granted in various European Union countries.
Note:
I am guessing this means that they will ONLY TARGET folks that already have glaucoma and if
this is true it will be on the label. I can't prove it but I think thats how they got the UK onboard.
OOps - the following contradicts what I just wrote
Our next question in queue is from Amit Bhalla of Citi.
Adam Darity
This is actually Adam in for Amit in for Amit tonight. I just wanted to follow-up about the FDA. Since you're resubmitting data that you've already previously submitted, what's the additional analysis here that the FDA is going to be considering anew, and how is that different from what they were considering the last time?
Charles Daniel Myers - Co-Founder, Chief Executive Officer, President and DirectorBasically, from the meeting we had in June, we felt like there was an opportunity to resubmit the data from the 2 original FAME trials with data around the benefit to risk associated more with chronic patients. When you talk to retinal specialists and certainly some of our advisors, the benefit-risk assessment for patients who are chronic patients in nature who have clearly had other therapies and are now moving into an area where one might look at the benefit to risk a little more broadly in that patient population, then perhaps you would with early onset or the data set, if you will, when we first submitted prior to the CRL. So perhaps, another way of saying that, is it's just a look at the benefit-risk ratio in chronic patients. We believe it could be looked at more broadly than
early onset.
I have no idea what the above means.
PRICING
Other than the public price in the U.K. that we submitted with our earlier NICE documentation for the U.K. price of GBP 5,500, and that is the public price, we will announce the Germany pricing 30 days prior to launch. So we will become out with that pricing in the coming months.
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